262 July 23, 2001
CONTENTS OF THIS ISSUE
- FDA approves GlaxoSmithKline's Safety
Tip-Lok vaccine delivery system for pediatric hepatitis A and hepatitis B
- Aventis Pasteur temporarily interrupts government
contract of DTaP (Tripedia) and DTaP-Hib (TriHIBit)
- OSHA begins enforcing needlestick safety provisions
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July 23, 2001
FDA APPROVES GLAXOSMITHKLINE'S SAFETY TIP-LOK VACCINE DELIVERY SYSTEM FOR PEDIATRIC HEPATITIS A AND HEPATITIS B
On June 15, 2001, GlaxoSmithKline (GSK) received U.S. Food and Drug Administration (FDA) approval for Safety Tip-Lok:
a prefilled Tip-Lok syringe packaged with a BD SafetyGlide needle for pediatric doses of Havrix (hepatitis
A vaccine) and Engerix-B (hepatitis B vaccine).
This system is designed to help protect health care workers from accidental needlestick injuries when giving hepatitis
A and B injections to children.
Authorized practitioners can request a free empty demonstration sample by calling (800) 680-9326.
For more information on federal needle safety requirements and a list of additional useful resources on needle safety,
see story number three.
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July 23, 2001
AVENTIS PASTEUR TEMPORARILY INTERRUPTS GOVERNMENT CONTRACT OF DTaP (TRIPEDIA) AND DTaP-Hib (TRIHIBIT)
On July 10, 2001, Aventis Pasteur notified the Centers for Disease Control and Prevention (CDC) that it would be
unable to meet its DTaP and DTaP-Hib vaccine government contract obligations for the next eight weeks. The
temporary delay resulted from a problem with the switch in production from ten-dose to single-dose vials.
Physicians who receive DTaP from health departments through the Vaccines For Children (VFC) program or 317 programs may
not be able to receive Aventis Tripedia (DTaP) or TriHIBit (DTaP-Hib) for the next eight weeks,
depending on the supply in individual states. However, states will be able to
provide DTaP vaccine manufactured by GlaxoSmithKline (Infanrix). GlaxoSmithKline has assured CDC that a
sufficient supply of DTaP vaccine will be made available to cover the current public purchase needs for the
DTaP five-dose schedule.
In order to ensure that adequate supplies of government-supplied DTaP vaccine exist for all providers, it is
important that everyone submit orders for no more than a one-month supply of DTaP at a time. CDC will continue to
work with state immunization programs to ensure a steady supply of DTaP. In the private market,
Aventis Pasteur will continue to supply DTaP vaccine at
the current rate of distribution. All currently available Aventis Pasteur DTaP
vaccine is safe and immunogenic.
The Aventis Pasteur and GlaxoSmithKline vaccines can be used interchangeably. CDC's Advisory Committee on
Immunization Practices has already established a recommendation regarding DTaP vaccine
interchangeability. The recommendation states: "When administered according to
their licensed indications, different diphtheria and tetanus toxoids and pertussis vaccines as single antigens
or various combinations, as well as the live and inactivated polio vaccines, also can be used
interchangeably." The 2000 Red Book from the American Academy of Pediatrics recommends
"in circumstances in which the previously administered product(s) is not readily
available, any of the other DTaP vaccines licensed for use in the primary series may be used."
IAC EXPRESS will publish further updates as they become available.
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July 23, 2001
OSHA BEGINS ENFORCING NEEDLESTICK SAFETY PROVISIONS
On July 17, 2001, OSHA began enforcement of the new requirements in its bloodborne pathogens standard. The new
requirements direct employers to
- involve frontline employees who provide direct patient
care in identifying and choosing safety devices
- maintain a log of injuries from contaminated sharps for
employers with 11 or more employees (Information in the sharps injury log must be
recorded and maintained in a manner that protects the privacy of the
- select safer needle devices as they become available
The requirements, intended to reduce needlesticks among
health care workers and others, took effect April 18, 2001. However, following the effective date,
OSHA instituted a 90-day period of "education and outreach" before enforcing
the new requirements. As of July 17, 2001, facilities can be fined for noncompliance with the standard.
States and territories that operate their own OSHA-approved programs must adopt the revisions to the federal bloodborne
pathogens standard, or a more stringent amendment to their own standard, by October 18, 2001.
To visit OSHA's website on needlestick prevention, which includes news releases, fact sheets, legislation, related
technical links, and more, go to: http://www.osha-slc.gov/SLTC/needlestick/
To obtain OSHA's technical background and summary on the revised bloodborne pathogens standard, go to:
To obtain OSHA's frequently asked questions on the revised bloodborne pathogens standard, go to:
To obtain OSHA's PowerPoint presentation on needlestick prevention, go to: http://www.osha-slc.gov/needlesticks/2001RevisedBBPStandardOutreach1.ppt
To obtain "Preventing Needlestick Injuries in Health Care Settings," a publication
from CDC's National Institute for Occupational Safety and Health, go to: http://www.cdc.gov/niosh/2000-108.html
To visit CDC's Division of Healthcare Quality Promotion page on bloodborne pathogens, go to:
To visit CDC's website on needle-free injection technology, go to: http://www.cdc.gov/nip/dev/jetinject.htm
To visit the website of the Exposure Prevention Information Network (EPINet) at the
University of Virgina, which includes a directory of resources on complying with
needlestick safety regulations, go to: http://www.med.virginia.edu/medcntr/centers/epinet/
For EPINet's extensive list of needle safety devices, go to: http://www.med.virginia.edu/medcntr/centers/epinet/products.html
For EPINet's list of state legislation on needle safety, go to:
The Safe Injection Global Network (SIGN) is an international organization dedicated
to needle safety. Visit: http://www.injectionsafety.org
The National Alliance for the Primary Prevention of Sharps Injuries website also
offers extensive information. Visit: http://www.nappsi.org/needlestick.shtml